Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis

The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].

The secondary objectives were:

• to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue;
• to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.

The duration of the study period for a participant was approximatively 44 weeks broken down as follows:

• Screening period up to 4 weeks,
• 24-week double-blind treatment period*,
• 16-week post-treatment elimination follow-up period.

'*' Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Inclusion Criteria:

• Definite MS diagnosis according to McDonald's criteria;
• Relapsing clinical course, with or without progression;
• Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);
• Stable dose of Glatiramer Acetate [GA] for at least 26 weeks prior to the screening visit;
• No onset of MS relapse in the preceding 60 days prior to randomization;
• Clinically stable for 4 weeks prior to randomization.

Exclusion Criteria:

• Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
• Pregnant or nursing woman;
• Alcohol or drug abuse;
• Use of cladribine, Mitoxantrone, or other immunosuppressant agents such as Azathioprine, Cyclophosphamide, Cyclosporin, Methotrexate or Mycophenolate before enrollment;
• Human immunodeficiency virus [HIV] positive status;
• Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.